BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1083378 · Received July 28, 2008

    Report

    Report Number
    3004209178-2008-04454
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 30, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    APPROXIMATELY 2 WEEKS AFTER IMPLANT, WHEN THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNED ON, THE DISPLAY SHOWED THE "CALL YOUR DOCTOR" ICON AND A POWER ON RESET (POR) ERROR CODE. THREE DAYS LATER, UNSPECIFIED TELEMETRY ISSUES WERE REPORTED. FIVE DAYS AFTER THAT, THE POR CONDITION WAS REPORTED AND A PHYSICIAN MODE RECHARGE (PMR) WAS ATTEMPTED; AFTER 1 HOUR, THERE WAS STILL NO COMMUNICATION WITH THE DEVICE, SO ANOTHER PMR WAS ATTEMPTED. THE INS WAS UNRESPONSIVE TO TELEMETRY ATTEMPTS BY THE PHYSICIAN PROGRAMMER, THE PATIENT PROGRAMMER, AND THE RECHARGER. THE INS WAS DETERMINED TO BE FLIPPED. A REVISION WAS PLANNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention IMPLANTED:| EXTENSION: MODEL 37081| PROGRAMMER: MODEL 37743 LOT# NKE105385N| ACCESSORY: MODEL 37752 LOT# NKA113609N| PROGRAMMER: MODEL 8840 LOT# UNKNOWN| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 39565| EXTENSION: MODEL 37081| IMPLANTED: